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Coumadin (Warfarin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Coumadin (Warfarin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1905)
Death (142)
Life Threatening Events (93)
Disability (40)

Reports by Reaction Type

International Normalised Ratio Increased (352)Anaemia (219)Fall (123)Gastrointestinal Haemorrhage (107)Haemorrhage (102)International Normalised Ratio Decreased (90)Epistaxis (87)Pulmonary Embolism (79)Deep Vein Thrombosis (78)Rectal Haemorrhage (73)Dyspnoea (71)International Normalised Ratio Fluctuation (69)

Below are a few examples of reports where side effects / adverse reactions may be related to Coumadin (Warfarin). For a complete list or a specific selection of reports, please use the links above.

Possible Coumadin side effects in 84 year old female

Reported by a consumer/non-health professional from France on 2012-08-27

Patient: 84 year old female

Reactions: Haemarthrosis, Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Other drugs received by patient: Toco; Metformin HCL; Celectol; Athymil; Imovane; Glyburide; Adalat; Cordarone; Cozaar; Calcium D3 Sandoz; Acetaminophen



Possible Coumadin side effects in 74 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 74 year old male, weighing 108.4 kg (238.5 pounds)

Reactions: International Normalised Ratio Increased, Expired Drug Administered, Intentional Drug Misuse

Drug(s) suspected as cause:
Coumadin
    Indication: Product Used FOR Unknown Indication

Coumadin

Tylenol-500
    Administration route: Oral

Tylenol-500
    Dosage: 2 caplets 2 times a day
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2012-06-01
    End date: 2012-07-03

Other drugs received by patient: Aricept; Vasotec; Vytorin



Possible Coumadin side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Surgery, Procedural Haemorrhage

Drug(s) suspected as cause:
Celebrex
    Dosage: unk

Coumadin
    Dosage: unk



Possible Coumadin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Rectal Haemorrhage, Deep Vein Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Thrombosis

Rebif
    Indication: Multiple Sclerosis
    Start date: 2009-11-19
    End date: 2010-01-01

Rebif
    Start date: 2010-01-01



Possible Coumadin side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 59 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Off Label Use, Procedural Complication, Pulmonary Artery Thrombosis, Treatment Noncompliance

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Product Used FOR Unknown Indication

Flolan
    Dosage: 32ngkm unknown
    Indication: Heart Disease Congenital
    Start date: 2011-05-10
    End date: 2012-08-07

Other drugs received by patient: Dobutamine



Possible Coumadin side effects in 84 year old female

Reported by a physician from France on 2012-08-27

Patient: 84 year old female

Reactions: Haemarthrosis, Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Other drugs received by patient: Cordarone; Metformin HCL; Calcium D3 Sandoz; Cozaar; Adalat; Acetaminophen; Athymil; Glyburide; Imovane; Celectol; Toco



Possible Coumadin side effects in 87 year old male

Reported by a consumer/non-health professional from France on 2012-08-24

Patient: 87 year old male

Reactions: Gastrointestinal Haemorrhage, Anaemia, Erosive Oesophagitis, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 1 df:kardegic 75 mg powder for oral solution in sachet
    Administration route: Oral
    Start date: 2012-02-01

Coumadin
    Dosage: 1 df:coumadine 2 mg scored tablet (warfarin sodium) 1 unk-2mar12(1 month) resumed unk date
    Administration route: Oral
    Start date: 2012-02-01

Other drugs received by patient: Furosemide; Fluticasone Propionate / Salmeterol; Procoralan; Spasfon; Atorvastatin; Levothyroxine Sodium



Possible Coumadin side effects in 87 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 87 year old female

Reactions: International Normalised Ratio Increased, Transfusion, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-08-27

Ventavis
    Dosage: 5 mcg, 6 x daily
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-02-24



Possible Coumadin side effects in 82 year old female

Reported by a consumer/non-health professional from Italy on 2012-08-24

Patient: 82 year old female

Reactions: Hypocoagulable State, Anaemia, Injury, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Other drugs received by patient: Nitroglycerin; Altiazem



Possible Coumadin side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Contusion, Palpitations, Extrasystoles, Tricuspid Valve Incompetence, Hypercoagulation, Deep Vein Thrombosis, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Dosage: unk
    Indication: Deep Vein Thrombosis

Nuvaring
    Indication: Contraception
    Start date: 2005-04-13
    End date: 2005-05-29

Other drugs received by patient: Vitamins (Unspecified)



Possible Coumadin side effects in 47 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 47 year old female

Reactions: Catheterisation Cardiac, Procedural Complication, Heart Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Tracleer
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Adcirca



Possible Coumadin side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Migraine, Pneumonia Primary Atypical, Lung Neoplasm, Haemorrhagic Disorder, Pulmonary Embolism, Hypercoagulation, Streptococcal Infection, Off Label Use, Lung Disorder, Menorrhagia, Muscle Spasms, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Anticoagulant Therapy
    Start date: 2009-12-01

Hormonal Contraceptives (Unspecified)
    Indication: Product Used FOR Unknown Indication

Nuvaring
    Indication: Menstrual Cycle Management
    Start date: 2007-01-01
    End date: 2009-12-31

Nuvaring
    Start date: 2009-06-01



Possible Coumadin side effects in 81 year old female

Reported by a consumer/non-health professional from France on 2012-08-23

Patient: 81 year old female

Reactions: Shock Haemorrhagic, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin



Possible Coumadin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 103.8 kg (228.5 pounds)

Reactions: Diabetes Mellitus, Oral Cavity Fistula, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Cardiomegaly, Oedema Peripheral, Pulmonary Oedema, Pneumonitis, Hyperparathyroidism Secondary, Hyperphosphataemia, Left Ventricular Hypertrophy, Coronary Artery Disease, Cardiomyopathy, Nephrosclerosis, Alpha Haemolytic Streptococcal Infection, Staphylococcal Infection, Ventricular Tachycardia, Compression Fracture, Nicotine Dependence, Somnolence, Fall, Hypoacusis, Plasma Protein Metabolism Disorder, Chest Pain, Bone Disorder, Depression, Umbilical Hernia, Emphysema, Cataract, Dyspnoea, Paraesthesia Oral, Gout, Muscular Weakness, Bundle Branch Block Left, Arrhythmia, Arthralgia, Sepsis, Mitral Valve Incompetence, Hypoalbuminaemia, Loose Tooth, Mononeuritis, Hypertensive Nephropathy, Coagulopathy, Extrasystoles, Osteomyelitis, Phosphorus Metabolism Disorder, Pericardial Effusion, Hypoaesthesia Oral, Cardiac Failure Congestive, Pneumonia, Anaemia, Gingival Disorder, Hypoaesthesia, Bacteraemia, Mastication Disorder, Haemorrhagic Diathesis, Venous Thrombosis, Sleep Apnoea Syndrome, Aortic Valve Incompetence, Excessive Granulation Tissue, Venous Occlusion, Atelectasis, Aortic Bruit, Constipation, Neuropathy Peripheral, Left Ventricular Dysfunction, Pleural Effusion, Scoliosis, Peripheral Vascular Disorder, Nephrogenic Anaemia, Hyponatraemia, Renal Failure Chronic, Osteoarthritis, Osteonecrosis of JAW, Bradycardia, Hypertension, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg
    Start date: 1997-12-04

Coumadin

Zometa

Other drugs received by patient: Alprazolam; Calcium Carbonate; Vincristine; Labetalol HCL; Paroxetine; Aspirin; Tagamet; Lodine; Doxorubicin Hydrochloride; Thalidomide; Allopurinol; Furosemide; Adriamycin PFS; Vancomycin; Hydralazine HCL; Metolazone; Neurontin; Dexamethasone; Pyridoxine HCL; Promethazine



Possible Coumadin side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Abdominal Pain, Migraine, Pain in Extremity, Nausea, Coagulopathy, Pulmonary Embolism, Treatment Noncompliance, Muscle Strain, Chest Pain, Hypertension, Cough, Deep Vein Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Coumadin
    Dosage: unk
    Indication: Prophylaxis
    Start date: 2009-12-19

Nuvaring
    Dosage: unk
    Indication: Contraception
    Start date: 2009-02-01
    End date: 2009-12-01



Possible Coumadin side effects in 84 year old male

Reported by a consumer/non-health professional from Italy on 2012-08-23

Patient: 84 year old male

Reactions: Hypocoagulable State, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Other drugs received by patient: Pantoprazole; Polase; Lorazepam; Bisoprolol Fumarate; Furosemide



Possible Coumadin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: International Normalised Ratio Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Dianeal
    Indication: Peritoneal Dialysis

Dianeal LOW Calcium W / Dextrose 1.5%
    Indication: Peritoneal Dialysis



Possible Coumadin side effects in 65 year old male

Reported by a consumer/non-health professional from Italy on 2012-08-23

Patient: 65 year old male

Reactions: Haematuria, Anaemia, Rectal Haemorrhage, Duodenal Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Dosage: 1df= 1dose
    Administration route: Oral
    Indication: Factor V Leiden Mutation
    Start date: 2008-01-01
    End date: 2012-07-28

Ibuprofen
    Dosage: 1df= 1dose
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Scopolamine
    Dosage: buscopan 20 mg/ml. 1df=1 dose
    Indication: Abdominal Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Other drugs received by patient: Allopurinol; Pentacol



Possible Coumadin side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Paresis, Drug Resistance, Antiphospholipid Antibodies Positive, Drug Hypersensitivity, Pulmonary Embolism, Vena Cava Filter Insertion, Joint Injury, Cholelithiasis, Anticoagulation Drug Level Below Therapeutic, Antiphospholipid Syndrome, Arthralgia, Alopecia, Cholecystectomy, Pulmonary Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Coumadin
    Dosage: 12 mg, qd
    Start date: 2011-09-01

Coumadin
    Dosage: unk
    End date: 2010-12-01

Coumadin
    Dosage: unk
    Indication: Anticoagulant Therapy
    Start date: 2009-08-01
    End date: 2009-12-01

Nuvaring
    Dosage: unk
    Indication: Contraception
    Start date: 2009-07-01
    End date: 2009-08-01



Possible Coumadin side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 62 year old male

Reactions: Haemoptysis, International Normalised Ratio Increased, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin



Possible Coumadin side effects in male

Reported by a pharmacist from United States on 2012-08-22

Patient: male, weighing 133.0 kg (292.6 pounds)

Reactions: Haemoglobin Decreased, Retroperitoneal Haematoma, Hypotension, Hypoxia, Epistaxis

Adverse event resulted in: death

Drug(s) suspected as cause:
Coumadin
    Dosage: 5mg, daily, po
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-04-12
    End date: 2012-04-16

Lovenox
    Dosage: 130mg, q12h, sq
    Indication: Atrial Fibrillation
    Start date: 2012-04-05
    End date: 2012-04-16

Other drugs received by patient: Gabapentin; Pravastatin; Aspirin; Fluconazole; Fuosemide; Meropenem; Digoxin; Insulin Lispro; Metoprolol Tartrate; Miralax; Prednisone; Pantoprazole



Possible Coumadin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Drug Ineffective, Coagulopathy, Haemorrhagic Anaemia, Toxicity To Various Agents, Kidney Transplant Rejection, Catheter Site Haemorrhage, Haematochezia, Aortic Valve Replacement, Hypertension, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Dosage: unk
    Indication: Aortic Valve Replacement

Prograf
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2007-12-25



Possible Coumadin side effects in 79 year old male

Reported by a pharmacist from Italy on 2012-08-22

Patient: 79 year old male

Reactions: International Normalised Ratio Increased

Drug(s) suspected as cause:
Azithromycin
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2012-05-28
    End date: 2012-05-30

Coumadin
    Dosage: 13.75 mg, weekly
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-09-06
    End date: 2012-05-31

Levofloxacin
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2012-05-31
    End date: 2012-06-05

Other drugs received by patient: Atorvastatin; Limpidex; Avodart; Enalapril Maleate; Rifaximin; Carvedilol



Possible Coumadin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Product Quality Issue, Nervous System Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Coumadin



Possible Coumadin side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient:

Reactions: Drug Resistance, Angina Pectoris, International Normalised Ratio Increased, Otitis Media Acute, Pulmonary Embolism, Hypercoagulation, Cardiomegaly, Acute Sinusitis, Depression, Bronchitis, Pharyngitis, Metabolic Syndrome, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Anticoagulant Therapy
    Start date: 2009-12-01
    End date: 2010-03-01

Nuvaring
    Indication: Contraception
    Start date: 2009-06-01
    End date: 2009-12-11

Nuvaring
    Indication: Menstrual Cycle Management
    Start date: 2009-06-01
    End date: 2009-12-11

Other drugs received by patient: Hydrochlorothiazide; Vitamin B Complex CAP; Hoodia Gordonii; Vitamins (Unspecified)



Possible Coumadin side effects in 84 year old female

Reported by a physician from France on 2012-08-22

Patient: 84 year old female

Reactions: Haemoglobin Decreased, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Coumadin
    Dosage: 1 df = two scored tablets daily
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-04-16
    End date: 2012-04-30

Pradaxa
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-05-01
    End date: 2012-05-02

Other drugs received by patient: Digoxin; Hyperium; Micardis; Amlodipine Besylate; Pravastatin; Lexomil; Polyethylene Glycol; Lansoprazole



Possible Coumadin side effects in 90 year old male

Reported by a pharmacist from United States on 2012-08-22

Patient: 90 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Cerebral Haemorrhage

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Coumadin



Possible Coumadin side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 47 year old female, weighing 79.0 kg (173.8 pounds)

Reactions: Muscle Haemorrhage, Overdose, International Normalised Ratio Increased, Compartment Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin

Letairis
    Dosage: tabs
    Administration route: Oral
    Start date: 2009-01-19

Treprostinil
    Dosage: 10mg/ml inj for inf,93.6mcg/kg;20dec11-unk,106.56mcg/kg;0.074mcg/kg;01aug12-unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-12-20

Other drugs received by patient: Digoxin; Revatio; Spironolactone



Possible Coumadin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: COR Pulmonale, Drug Interaction, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Coumadin

Digoxin

Revatio
    Dosage: 60 mg
    Indication: Lung Disorder
    Start date: 2011-11-01



Possible Coumadin side effects in 69 year old male

Reported by a pharmacist from Italy on 2012-08-21

Patient: 69 year old male

Reactions: International Normalised Ratio Increased

Drug(s) suspected as cause:
Armodafinil
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Oral Candidiasis
    Start date: 2012-05-09
    End date: 2012-05-21

Coumadin
    Dosage: 17.5 mg, weekly
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2007-02-21
    End date: 2012-05-20

Other drugs received by patient: Cordarone; Omeprazole; Bisoprolol Fumarate

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